Detectnet (Intravenous)

Copper Cu 64 dotatate injection is used with a PET scan (positron emission tomography) to locate somatostatin receptor positive neuroendocrine tumors (NETs).

Copper Cu 64 dotatate is a radiopharmaceutical. Radiopharmaceuticals are radioactive agents that may be used to find and treat certain diseases or to study how the body's organs work.

This medicine is to be given only by or under the direct supervision of a doctor who has specialized training in nuclear medicine.

It is very important that your doctor monitors you closely while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and if you should continue to receive it.

This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Contact your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

While receiving this medicine, you will be exposed to radiation and have an increased risk of cancer. If you have any questions about this, talk to your doctor.

In deciding to use a diagnostic test, you and your doctor need to consider any risks of the test compared to the benefits it may provide. Other factors can also influence test results. For this test, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care professional know about any other allergies you may have, including allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how age affects the use of copper Cu 64 dotatate injection in children. Safety and effectiveness have not been established for this group.

Geriatric

Current studies have not found any age-related issues that would limit the use of copper Cu 64 dotatate injection in older adults. However, older patients are more likely to have heart, kidney, or liver issues, which may require caution when using copper Cu 64 dotatate injection.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medicine while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might adjust the dose, or other precautions may be necessary. It is very important that your healthcare professional knows if you are taking any of the medicines listed below when you are receiving this diagnostic test. The following interactions are based on their potential significance but may not include all relevant interactions.

Using this diagnostic test with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Lanreotide
• Octreotide
• Pasireotide

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Chest tightness
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing
• unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Feeling of warmth
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Detectnet

Available Dosage Forms:

• Solution

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins just before you have a PET scan.

Drink enough water to be hydrated before the PET scan.

You will need to urinate right away and as often as possible for at least 1 hour after the PET scan.